Class I · High risk
Volu-Sol Handrub Sanitizing Solution
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
FDA Drug Recalls
832 recalls, newest first
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Class II · Moderate risk
Prednisone Tablets
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk
Just Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
Always Be Clean Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
UltraCruz Hand Sanitizing Gel Antimicrobial
Subpotent drug
Class I · High risk
Incredible Products Gelbac T Antibacterial Hand Gel
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Tablet/Capsule Specification; complaint of bulging tablet
Class II · Moderate risk
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes
Lack of Assurance of Sterility
Class II · Moderate risk
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine 50 mg Infusion
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Command Brands GelAnti Bac Instant Hand Sanitizer
CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk
Day & Night Pack Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops with 4% Lidocaine
cGMP Deviations.